Entera Bio to report results from Phase 2b study for oral PTH in September
The company said, "Phase 2b Study for Oral PTH in hypoparathyroidism: Oral PTH for hypoparathyroidism is Entera's second major proprietary pipeline program. Entera completed in 2018 a two-part Phase 2 trial in patients with hypoparathyroidism that was designed to evaluate the pharmacokinetic and pharmacodynamic profiles of its oral PTH drug and injectable PTH. Results from Part 1 of this study, reported in 2018, demonstrated a positive impact of Oral PTH on three metabolic parameters - serum calcium, phosphate, and 1,25-dihydroxyvitamin D - in patients with hypoparathyroidism. There was also a decrease in 24-hour urine calcium in the patients treated with Oral PTH. Part 2 of this PK/PD study evaluated a three times per day treatment regimen with a high and low dose of Oral PTH, as well as additional Natpara treatments. Results from this study are expected to be reported in September 2019 at an upcoming scientific conference and are subsequently expected to be submitted for peer review publication in 2020. These data will provide input for the design of the Company's anticipated Phase 3 registration clinical trials."